search
Back to results

mHealth for Prevention of Childhood Obesity in Mexico (mHealth)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Control group
SMS´s sending by cell phone for behavior change
Sponsored by
Mexican National Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Randomised controlled trial, Text messaging, Infant feeding practice, health unit, BMI, Mobile phone, prevention

Eligibility Criteria

undefined - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary caregivers whose beneficiaries children are cared in the health units selected for the study and who have a cell pone in home
  • Health personnel who provides services to Prospera population in the health units selected for the study and that have a cell pone
  • Primary caregiver, must care for at least one child under 60 months users of the health units selected for the study

Exclusion Criteria:

  • Primary caregivers and health personnel who do not have a cell pone or who do not have connectivity in their communities
  • Health personnel, who have been in office for a least 3 months

Sites / Locations

  • Ministry of Health of Morelos State

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Intervention

Arm Description

Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition)

Intervention group will receive SMS messages sent through a cell pone in addition to the control group receive (standard child care in health units plus exposure to EsIAN)

Outcomes

Primary Outcome Measures

prevalence of overweight and obesity
Through the measurements of weight and height to children under 60 months, the estimator of body mass index adjusted for age will be calculated to determine prevalence of overweight (+1 SD. Z score ) and obesity (+2 SD Z score).

Secondary Outcome Measures

Proportion of caregivers / mothers with correct infant feeding practices scale
Practices related to breastfeeding, complementary food and healthy nutrition during childhood (scale of 0-20 values , which high scores >15 is correct)
Proportion of caregivers / mothers with correct physical activity practices scale
Practices of physical activity to less 5 years old (scale of 0-20 values , which high scores >15 is correct)

Full Information

First Posted
October 31, 2019
Last Updated
September 13, 2021
Sponsor
Mexican National Institute of Public Health
Collaborators
UNICEF
search

1. Study Identification

Unique Protocol Identification Number
NCT04250896
Brief Title
mHealth for Prevention of Childhood Obesity in Mexico
Acronym
mHealth
Official Title
Using Behavioral Science and mHealth Tools for Early Prevention of Childhood Obesity in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mexican National Institute of Public Health
Collaborators
UNICEF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: The sending of text messages (short messaging service, SMS) has been proven as an effective strategy in behavior change. In Mexico, the Strategy of Comprehensive Care for the Nutrition (EsIAN for its acronym in Spanish ) focuses on improving access to information for the main caregivers of child beneficiaries on the practice of infant feeding and healthy physical activity. Objective: To assess whether the mHealth (or mobile health) strategy or the sending of SMS has an effect on knowledge, attitudes, intentionality, perceived control and practices to prevent childhood malnutrition in a population living in poverty. Design: Randomized effectiveness trial by conglomerates. Participants: 400 primary caregivers of children <59 months and health personnel working in the health units included in the study. Control group: Healthy child care in standard health units plus exposure to EsIAN. Intervention group: In addition to the control group, the SMS are sent through a cell pone through the RapidPro platform on practices related to prevention of child malnutrition (in primary caregivers) and the reinforcement of counseling for the prevention of infant malnutrition (with health personnel). Randomization: The first level health units were stratified by state (Morelos or Yucatan); rural and urban area and affiliation institution (Secretary of Health or Mexican Institute of Social Security); and randomized to be assigned to the control or intervention group; 400 primary caregivers of children <59 months in total will be included for the study. Main measures of interest: State of nutrition and knowledge, attitudes or practices on breastfeeding, physical activity, adoption and preparation of healthy foods and beverages in primary caregivers of children<5 years old; and advice on the key messages of EsIAN by health providers.
Detailed Description
RapidPro is a tecnological platform of programming of short messaging service (SMS) for cell phone. Morelos is the name of one of the central states of Mexico Yucatan is the name of one of the south states of Mexico

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Randomised controlled trial, Text messaging, Infant feeding practice, health unit, BMI, Mobile phone, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition of Mexico). At the same time as the intervention group, in addition to the control group, will receive SMS through a cell pone on practices related to the prevention of infant malnutrition (in primary caregivers) and the strengthening of counseling for the prevention of infant malnutrition with health providers.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The randomized unit is the health center
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Control group will receive standard child care in health units plus exposure to EsIAN (Strategy of Integral Attention to Nutrition)
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group will receive SMS messages sent through a cell pone in addition to the control group receive (standard child care in health units plus exposure to EsIAN)
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Standard child care in health unit plus exposure to EsIAN
Intervention Type
Behavioral
Intervention Name(s)
SMS´s sending by cell phone for behavior change
Intervention Description
SMS messages sent through a cell pone through the RapidPro platform on practices related to the prevention of infant malnutrition to primary caregivers and the strengthening of counseling for the prevention of infant malnutrition with health providers.
Primary Outcome Measure Information:
Title
prevalence of overweight and obesity
Description
Through the measurements of weight and height to children under 60 months, the estimator of body mass index adjusted for age will be calculated to determine prevalence of overweight (+1 SD. Z score ) and obesity (+2 SD Z score).
Time Frame
basal and through study completion, an average of 9 months.
Secondary Outcome Measure Information:
Title
Proportion of caregivers / mothers with correct infant feeding practices scale
Description
Practices related to breastfeeding, complementary food and healthy nutrition during childhood (scale of 0-20 values , which high scores >15 is correct)
Time Frame
basal and through study completion, an average of 9 months.
Title
Proportion of caregivers / mothers with correct physical activity practices scale
Description
Practices of physical activity to less 5 years old (scale of 0-20 values , which high scores >15 is correct)
Time Frame
basal and through study completion, an average of 9 months.
Other Pre-specified Outcome Measures:
Title
knowledge and attitudes related to infant feeding practices and physical activity of child
Description
scales of knowledge and attitudes about nutrition and physical activity of the child (scale of 0-5 values, which high scores is agreement or very important)
Time Frame
basal and through study completion, an average of 9 months.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary caregivers whose beneficiaries children are cared in the health units selected for the study and who have a cell pone in home Health personnel who provides services to Prospera population in the health units selected for the study and that have a cell pone Primary caregiver, must care for at least one child under 60 months users of the health units selected for the study Exclusion Criteria: Primary caregivers and health personnel who do not have a cell pone or who do not have connectivity in their communities Health personnel, who have been in office for a least 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabelle Bonvecchio, PhD
Organizational Affiliation
Mexican National Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health of Morelos State
City
Cuernavaca
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

mHealth for Prevention of Childhood Obesity in Mexico

We'll reach out to this number within 24 hrs